The role of contract development and manufacturing organizations (CDMOs) serving the pharmaceutical industry used to be reasonably straightforward—cost-effective services and efficient capacity for the manufacture of well-established active pharmaceutical ingredients (APIs or drug substance) and drug products. While crafting a request for proposal (RFP) to capture the information innovators need to select a CDMO partner has always been critical; it has grown increasingly complicated.

Today, CDMOs fulfill more diverse needs than ever, from traditional capacity and manufacturing efficiency to turnkey solutions for partially or entirely virtual development organizations. CDMOs can also be highly specialized providers of technologies and expertise for novel advanced therapeutics.

Given the increasingly diverse therapeutics, processes, and go-to-market strategies innovators require from CDMOs, a comprehensive RFP is more critical than ever.

THE ROLE OF A WELL-CRAFTED RFP

Ultimately, an effectively designed RFP will result in selecting a biologics CDMO that can manufacture your product at the needed scale and in your required timeline. Additionally, the CDMO will need to understand phase-appropriate guidances, have a flexible and skilled project team, offer appropriate program support, operate utilizing a robust cGMP-compliant quality management system, and have the advanced technologies required to help you mitigate risks and speed up time to market.

Providing a well-thought-out RFP will help potential partners understand your needs and objectives going into the proposal process and make your biologics CDMO selection process more effective.

NEEDS & GAP ANALYSES: THE CORNERSTONES OF THE RFP CREATION PROCESS

Assembling a multidisciplinary team of executive management, scientific staff, and clinical and financial team members to conduct thorough needs and gap analyses will create a strong foundation for your RFP. These analyses will assess the capabilities and capacity you need to produce your product, and outline the level of expertise your organization requires in a biologics CDMO partner.

Some key questions to consider when conducting your needs and gap analyses include:

• What are our timeline and capacity requirements?
• What is our budget for this program, and are their milestones directly tied to our funding/organization’s financial health?
• How much biologics process development assistance do we require?
• What are the gaps in our organization’s drug and biologics process development expertise?
• Are we lacking understanding of our therapeutic’s critical quality attributes?
• Where are the gaps in our current analytical and CMC packages?
• Which novel technologies are needed to develop our therapeutic?
• What are the known risks in our biologics development program?
• Are we seeking an integrated CDMO partner to serve our needs throughout our product’s lifecycle?
• Do we require regulatory and filing support?
• In many cases, development teams are unaware of some program needs or gaps that may put their program and timelines at risk. However, an experienced CMDO will be able to spot gaps or needs that weren’t identified initially and make recommendations accordingly.

• Further drug product detail—dose, dosage form, scale, drug delivery mechanisms, etc.
• Information available to transfer to the CDMO, such as manufacturing process details, analytical test method procedures, reference standards, etc.
• Previous manufacturing history
• Current process flow
• Any known key processing parameters
• Known gaps in product or process understanding
• Known product or process risks
• Specific known deliverables/expertise needed, such as process, formulation, and/or analytical method development, stability study execution, etc.
• Release and stability testing requirements with specifications, as available
• Needed program management support